New Dupixent® (dupilumab) Data Showcasing Improvements Across Four Type 2 Inflammatory Diseases to be Presented at 2021 AAAAI Annual Meeting

INVESTORS & MEDIA

INVESTORS
& MEDIA

Regeneron Pharmaceuticals, Inc.
February 1, 2021 at 9:59 AM EST

New Dupixent® (dupilumab) Data Showcasing Improvements Across Four Type 2 Inflammatory Diseases to be Presented at 2021 AAAAI Annual Meeting

TARRYTOWN, N.Y. and PARIS, Feb. 1, 2021 /PRNewswire/ -- 

Improvements were noted across key disease measures in certain patients with asthma, atopic dermatitis, eosinophilic esophagitis and chronic rhinosinusitis with nasal polyposis

New analyses build on a robust body of evidence reinforcing the role of Dupixent in certain diseases driven by type 2 inflammation

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced new data further examining Dupixent® (dupilumab) in diseases driven by type 2 inflammation including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic esophagitis. These data will be presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) Virtual Annual Meeting, taking place from February 26 to March 1.

Abstracts have been published in an online supplement to The Journal of Allergy and Clinical Immunology (JACI) and include:

Atopic Dermatitis
New analyses evaluate the efficacy of Dupixent in children with severe atopic dermatitis with atopic comorbidities.

  • Oral Abstract 461A (February 27, 5:10 pm - 6:25 pm ET): Dupilumab Improves Signs and Symptoms of Severe Atopic Dermatitis in Children Aged 6–11 Years With and Without Comorbid Allergic Rhinitis, Lisa Beck
  • Poster 99: Dupilumab Improves Signs and Symptoms of Severe Atopic Dermatitis in Children Aged 6–11 Years With and Without Comorbid Asthma, Mark Boguniewicz

Asthma
New analyses evaluate the efficacy of Dupixent in moderate-to-severe asthma patients with an allergic phenotype over the long-term, as well as difficult-to-treat patients. Analyses also explore the potential of clinical remission in patients with moderate-to-severe disease with type 2 inflammation.

  •  Featured Poster 010 (February 26, 4:35 pm5:50 pm ET): Dupilumab Treatment Leads to Clinical Asthma Remission in Patients With Uncontrolled Moderate-to-Severe Asthma With Type 2 Inflammation, Ian Pavord
  • Poster 183: Dupilumab Efficacy in GINA-Defined Difficult-to-Treat Type 2 Asthma Patients in the LIBERTY ASTHMA QUEST Study, Klaus Rabe
  • Poster 184: Long-Term Efficacy of Dupilumab in Patients With Asthma With an Allergic Phenotype Rolled Over From LIBERTY ASTHMA QUEST: LIBERTY ASTHMA TRAVERSE Study, Lawrence Sher

Eosinophilic Esophagitis
New analysis further explores the impact of Dupixent on health-related quality of life (HRQoL) in patients with eosinophilic esophagitis. The use of Dupixent in eosinophilic esophagitis is currently under clinical investigation and its safety and efficacy have not been fully evaluated by any regulatory authority.

  • Poster 290: Dupilumab Improves Health-Related Quality of Life (HRQoL) and Reduces Symptom Burden in Patients with Eosinophilic Esophagitis (EoE): Results From Part A of a Randomized, Placebo-Controlled Three-Part Phase 3 Study, Evan Dellon

Chronic Rhinosinusitis with Nasal Polyposis
New analyses examine the burden on HRQoL in patients with severe CRSwNP, and the impact on objective and subjective disease measures with Dupixent treatment.

  • Poster 423: A Responder Analysis to Demonstrate Dupilumab Treatment Effect Across Objective and Patient-Reported Subjective Endpoints For Patients With Severe Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Claus Bachert
  • Poster 425: Health-Related Quality of Life Impairment Among Patients With Severe Chronic Rhinosinusitis With Nasal Polyps in the SINUS-24 Trial, Jorge Maspero

Cross-Indication Blood Eosinophils
New analysis assesses the effect of Dupixent on blood eosinophils over time across approved and investigational indications. 

  • Poster 447: Effect of Dupilumab Treatment on Blood Eosinophil Levels in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Eosinophilic Esophagitis (EoE), or Atopic Dermatitis (AD), Michael Wechsler

Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, that was invented using Regeneron's proprietary VelocImmune® technology. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis asthma, CRSwNP and eosinophilic esophagitis.

About Dupixent
In the United States and Europe, Dupixent is approved for patients 6 years and older with moderate-to-severe atopic dermatitis, patients 12 years and older with moderate-to-severe asthma, and in adults with uncontrolled CRSwNP. Dupixent is also approved in one or more of these indications in more than 60 countries around the world and more than 200,000 patients have been treated globally.

Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupixent should be administered by a caregiver.

Dupixent was invented using Regeneron's VelocImmune® technology that utilizes a proprietary genetically-engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies. VelocImmune technology has been used to create multiple antibodies including Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab) and Kevzara® (sarilumab), which are approved in multiple countries around the world. Regeneron also applied this technology in 'rapid response' efforts to develop the first FDA-approved treatment for Zaire ebolavirus and a potentially preventative and therapeutic medicine for COVID-19, which was recently granted Emergency Use Authorization (EUA) by the FDA.

Dupilumab Development Program
To date, dupilumab has been studied in more than 10,000 patients across 50 clinical trials in various chronic diseases driven by type 2 inflammation.

In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes, including pediatric asthma (6 to 11 years of age, Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), and food and environmental allergies (Phase 2). These potential uses are investigational, and the safety and efficacy of dupilumab in these conditions have not been fully evaluated by any regulatory authority. Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

INDICATIONS

DUPIXENT is a prescription medicine used:

  • to treat people aged 6 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 years of age.
  • with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 12 years of age.
  • with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.

IMPORTANT SAFETY INFORMATION & INDICATIONS

Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®.

Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:

  • have eye problems
  • have a parasitic (helminth) infection
  • are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with DUPIXENT.
  • are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
    • There is a pregnancy exposure registry for women who take DUPIXENT during pregnancy to collect information about the health of you and your baby. Your healthcare provider can enroll you or you may enroll yourself. To get more information about the registry call 1–877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/.
  • are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.  

Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have atopic dermatitis or CRSwNP, and also have asthma. Do not change or stop your corticosteroid medicine or other asthma medicine without talking to your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicine to come back.

DUPIXENT can cause serious side effects, including:

  • Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: breathing problems, fever, general ill feeling, swollen lymph nodes, swelling of the face, mouth and tongue, hives, itching, fainting, dizziness, feeling lightheaded (low blood pressure), joint pain, or skin rash.
  • Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.
  • Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by DUPIXENT. Tell your healthcare provider right away if you have: rash, shortness of breath, persistent fever, chest pain, or a feeling of pins and needles or numbness of your arms or legs.

The most common side effects by indication are as follows:

  • Atopic dermatitis: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, and cold sores in your mouth or on your lips.
  • Asthma: injection site reactions, pain in the throat (oropharyngeal pain), and high count of a certain white blood cell (eosinophilia).
  • Chronic rhinosinusitis with nasal polyposis: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, high count of a certain white blood cell (eosinophilia), trouble sleeping (insomnia), toothache, gastritis, and joint pain (arthralgia).

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Use DUPIXENT exactly as prescribed. Your healthcare provider will tell you how much DUPIXENT to inject and how often to inject it. DUPIXENT is an injection given under the skin (subcutaneous injection). If your healthcare provider decides that you or a caregiver can give DUPIXENT injections, you or your caregiver should receive training on the right way to prepare and inject DUPIXENT. Do not try to inject DUPIXENT until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that DUPIXENT be administered by or under supervision of an adult. In children younger than 12 years of age, DUPIXENT should be given by a caregiver.

Please see accompanying full Prescribing Information including Patient Information.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

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SOURCE Regeneron Pharmaceuticals, Inc.